With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management. These include significant roles in more than 75 submissions and, in several cases, leading the entire submission team overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.